An interventional study of Education with EBP and This is a pre- and post- quasi-experimental study. in Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI) and Pressure Ulcer (PU), sponsored by Hiroshima University. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Hiroshima University · Not applicable, Interventional, and Health services research
Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as Ventilator Associated Pneumonia (VAP), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU), and Central Line-Associated Bloodstream Infection (CLABSI). VAP, PU, and MDRPU are significant indicators of the quality of care, while CLABSI is a critical marker of healthcare quality in ICUs, as it is largely preventable through strict adherence to infection control protocols.
VAP is a lung infection that occurs in patients receiving mechanical ventilation for more than 48 hours. A PU is defined as localized damage to the skin or underlying tissue caused solely by pressure, while MDRPUs may also result from friction or pressure from medical devices or other objects. CLABSI is a severe infection caused by improperly inserted or maintained central venous catheters, which underscores the need for stringent catheter management protocols.
General Objective:
The objective of this study is to evaluate whether implementing EBP and changing nurses' competency (skill, knowledge, practice, and attitude) can reduce ICU adverse events such as VAP, PU, MDRPU, and CLABSI, and improve patient outcomes.
Specific Objectives:
Hypothesis:
H1- Hypothesize that training on EBP and its implementation in ICU settings will improve nurses' competency (Skill, knowledge, practice and attitude).
H2- Hypothesize that implementation of EBP by trained ICU nurses will reduce adverse events-such as VAP, pressure ulcers, medical device-related PU, and CLABSIs-and improve overall patient outcomes.
These research consist of two studies:
Evaluating the effect of EBP training on ICU nurses' competency (skill, knowledge, practice, and attitude) regarding EBP for CLABSI, PU, and MDRPU in an ICU setting.
A pre- and post-quasi-experimental study will be conducted over a 16-month period, with a total data collection period of 6 months, to evaluate nurses' competency. The study consists of a recruitment period (1 month), nurses' baseline data collection (1 month), nurses' EBP training with midline data collection (2 months), and nurses' endline data collection during EBP implementation (2 months).
Study nurses will receive EBP training and appropriate equipment for patient management. EBP education and training will be provided with necessary equipment, such as a closed suction catheter, an endotracheal tube, a suction device, and a mouth care brush. In this study, global standard equipment will be used to ensure patient safety.
A pre- and post-quasi-experimental design with a non-equivalent control group (Study 1, Phase 1 data used as historical data) will be applied by comparing the rate of adverse events such as VAP, CLABSI, PU, and MDRPU before and after the EBP intervention (2-month baseline data and 2-month intervention data will be collected).
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 272 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Trial 1 \& 2-
Inclusion Criteria:
Nurse
Exclusion Criteria:
Nurse
Nurses: All nurses who work at GICU of DMCH Patients: all patients who will admit at the assigned GICU during the study period of DMCH
Behavioral: Education with EBP · Behavioral: This is a pre- and post- quasi-experimental study.
Trial 1: Nurse's EBP training ( VAP, PU, MDRPU, CLABSI management), online lecture, 2 hours lecture and 3 hours skill training for nurses training. Trail 1 we use advanced equipment necessary for EBP implementation for VAP, PU, MDRPU and CLABSI management, and EBP-trained nurses implementation for all this management.
We will use advanced equipment and implement EBP (VAP, PU, MDRPU and CLABSI management) for patients by trained nurses and check the outcome of the patients. We will compare pre and post findings for this study.
The nurse's skill related to the PU, MDRPU and CLABSI total score measured by the researcher-developed checklist
1\. The nurse's skill and knowledge related to the PU, MDRPU and CLABSI checklist. Researcher developed checklist, 50 items with 0: not correct/did not do, 1: partially correct, 2: correct. Score range 0-114.
Time frame: 6 month data collection and total time frame of this study 16 months
Incidence rates of PU, MDRPU and CLABSI.
The incidence rate of PU was calculated as the number of newly developed pressure ulcers after hospitalization per 1000 person-days at risk. The incidence rate of MDRPU was calculated as the number of newly developed MDRPU cases per 1000 patients assessed. The incidence rate of CLABSI was calculated as the number of CLABSI cases per 1000 central line-days. Data will be collected: Patients' demographic data (age, sex, occupation etc.) Medical past and current history (diagnosis, treatment, medication, hospitalization). Reasons and date to be admitted to ICU. Treatment in ICU. Daily laboratory data taken in ICU. Daily biological data including vital signs. Results of patients' stay during ICU. Diagnosis of PU, MDRPU and CLABSI included of this list.
Time frame: 2 month for data collection and total time frame 16 months.
Nurses' knowledge, Attitude and Practice (KAP) related to the PU, MDRPU and CLABSI prevention measured by the researcher-developed scale based on Knowledge of EBP guidelines for the PU, MDRPU and CLABSI prevention scale
Nurses attitude, practice and knowledge related PU, MDPU and CLABSI related prevention scale. The researcher makes an attitude, practice and knowledge related of EBP guideline for PU, MDPU and CLABSI question Total item 22 and validity was tested by ICU and PU specialized nurses in Japan. Knowledge was assessed using multiple-choice questions, with one correct answer among four options. Each correct response was awarded a score of 1, and incorrect or "don't know" responses were scored 0. Attitude and practice were measured using a Likert scale, with responses indicating the degree of agreement or frequency.
Time frame: Total data collection time 6 months within 16 months
Rate (number of patients) of each stage of PU and MDRPU
After diagnosis of sore we measured stage of PU and MDRPU. Number of ICU patients developing PU and MDRPU categorized by stage (Stage I-IV). Unit of Measure: Number of patients per PU/MDRPU stage.
Time frame: Total 2 months
Micro-organism link to CLABSI
After diagnosis of CLABSI then identify what kind organism relate to CLABSI. Type and frequency of microorganisms identified in laboratory-confirmed CLABSI cases. Unit of Measure: Number of cases per microorganism.
Time frame: 2 months
Incidence and rate of VAP
Incidence rate of VAP per 1000 ventilator days. Unit of Measure: VAP cases per 1,000 ventilator days
Time frame: 2 months
Mortality and morbidity rate of adverse events
Mortality and morbidity rate of ICU patients All-cause mortality among ICU patients during the study period. Unit of Measure: Percentage (%)。Occurrence of ICU-related adverse events (VAP, CLABSI, PU, MDRPU). Unit of Measure: Number of patients with adverse events.
Time frame: 2 months
Average length of stay ICU patients
Average length of stay ICU patients. Mean length of stay in the intensive care unit for enrolled patients. Unit of Measure: Days (mean ± SD).
Time frame: 2 months
Survival rate of ICU
Average survival rate of ICU. Data will be collected: Length of stay and survival rate. Proportion of enrolled patients alive at ICU discharge. Unit of Measure: Percentage (%) of patients surviving to ICU discharge.
Time frame: 2 months
APACHE II score
Will be collected from patient record file. Sum Acute Physiology Points + Age Points + Chronic Health Points = APACHE II total (range 0-71). APACHE II total score (integer). Optionally report distribution (mean ± SD) or stratify by score ranges.
Time frame: 2 months
SOFA score
Will be collected from patient record file. Sum Acute Physiology Points + Age Points + Chronic Health Points = APACHE II total (range 0-71). APACHE II total score (integer). Optionally report distribution (mean ± SD) or stratify by score ranges. Use worst values within first 24 h for baseline SOFA. For organ-dysfunction trajectory, compute daily SOFA scores。Sum component scores → SOFA total (0-24). SOFA total score (integer). Can also report number/proportion with increase ≥2 points.
Time frame: 2 months
GCS score
Total GCS = E + V + M (range 3-15). Record at ICU admission (worst value in first 24 h for scoring systems). Note if patient is sedated or intubated - document sedation/intubation; if intubated, record "V = T" and use local protocol for scoring (some protocols assign V=1 or use best pre-sedation score). Unit / reporting: GCS total (3-15). Report component scores if relevant.
Time frame: 2 months
Plan to share: No — IPD will not be share due to personal confidentiality of the participants. When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for May 2026, 3 months later.
Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 3 months is below that.
Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pneumonia, Ventilator-Associated →
Hiroshima University